SeaSpine Inc
FDA Regulatory Profile
SeaSpine Inc has 1 FDA recall, 4 inspections, 33 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-1841-2014 · Class II · May 21, 2014
- Latest inspection
- Nov 17, 2016 · NAI
- Latest 510(k)
- Aug 3, 2023
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 33 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 4 | Oct 25, 2026 | Not stated | Current |
|---|
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1841-2014 | Class II | Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used… | May 21, 2014 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Nov 17, 2016 | Vista, CA | Biologics | No Action Indicated (NAI) | 3003790069 |
| Sep 19, 2014 | Vista, CA | Devices | No Action Indicated (NAI) | 3003790069 |
| Jun 26, 2012 | Vista, CA | Biologics | Voluntary Action Indicated (VAI) | 3003790069 |
| Jan 15, 2009 | Vista, CA | Devices | No Action Indicated (NAI) | 3003790069 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231654 | NorthStar OCT System | Aug 3, 2023 |
| K212135 | Dry DBM- A Putty | Oct 4, 2021 |
| K150469 | Integra Laminoplasty System | Mar 23, 2015 |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene… | Dec 18, 2014 |
| K133418 | INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM | May 1, 2014 |
| K132859 | INTEGRA FACET FIXATION SYSTEM | Nov 18, 2013 |
| K121924 | INTEGRA INTERSPINOUS PROCESS SYSTEM | Sep 4, 2013 |
| K130830 | INTEGRA LAMINOPLASTY SYSTEM | May 9, 2013 |
| K122571 | MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM | Dec 12, 2012 |
| K112206 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | Jan 25, 2012 |
| K111671 | SEASPINE MONOPOLAR PROBE SYSYEM | Dec 28, 2011 |
| K102026 | SEASPINE SPACER SYSTEM | May 12, 2011 |
| K103297 | REDONDO-L | Jan 27, 2011 |
| K092521 | ZUMA-C | Apr 13, 2010 |
| K082309 | CAMBRIA | Apr 9, 2009 |
| K083338 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | Feb 2, 2009 |
| K083089 | NEWPORT SPINAL SYSTEM | Jan 13, 2009 |
| K082926 | ZUMA, MODEL 55-XXXX/56-XXXX | Dec 22, 2008 |
| K082310 | HOLLYWOOD, PACIFICA, REDONDO, VENTURA | Nov 10, 2008 |
| K072729 | SIERRA | Apr 17, 2008 |